The GMP code requires that manufacturers run a “statistically significant” number of tests on product, and assumes that they maintain control over their processes. However, in practice, testing of batches is currently between 10-30 samples. As more drug manufacturers implement at-line, online or inline process analyzers, the number of tests run could potentially increase dramatically.

The annual IFPAC conference has become one of the more fruitful events for those wishing to stay on the cutting edge of process analytical technologies and Quality by Design. IFPAC is now promoting its 2012 event (see press release below), and we’re glad to help get the word out.

The International Forum for Process Analytical Technology (IFPAC) is often seen more as a networking event for those working on PAT and QbD, rather than a groundbreaking conference displaying radical innovations. Last month, IFPAC 2011 in Baltimore brought some of the same old presentations, but also a few surprises, including an emphasis on biopharmaceutical PAT and more practical case studies showing what is, rather than what may, be done with PAT and QbD.

A presentation at IFPAC last Thursday brought on some heated debate about the Design Space, and just how dynamic it can, or should, be. Should any changes due to unanticipated “real world” situations necessarily trigger the development of a new design space, and post-approval change filings and more testing?